Disposable ECMO Heat-Exchange Circuit for Mobile Temperature Control
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Solution Overview
Problem
Current temperature management systems for ECMO/ECLS therapy are prone to contamination due to their design with water reservoirs and fixed pumps, making cleaning complex and risky, and they are not suitable for mobile use, leading to temperature loss and increased energy requirements for patients.
Innovation Solution
A disposable fluid circuit encapsulated from the patient's blood circuit, using a sterile disposable and a heating unit to regulate temperature via a heat exchanger, with components designed for single-use and easy cleaning, eliminating direct contact with the fluid and reducing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If a water reservoir and fixed pump system is used for temperature management, then temperature control capability is provided, but contamination risk increases and cleaning becomes complex
Solution Approach 1:
The patent employs a disposable fluid circuit that is discarded after single use, eliminating the need for complex cleaning and sterilization procedures. This disposable circuit includes all fluid-containing components (tubes, reservoirs, pumps) that come into contact with the temperature management fluid, ensuring no contamination risk while maintaining effective temperature control capability.
Solution Approach 2:
The system is divided into a reusable main unit (providing temperature control functionality) and a disposable fluid circuit (containing all fluid-contact components). This segmentation allows the critical fluid pathway to be easily replaced without affecting the main temperature control system, resolving the contradiction between maintaining temperature control capability and eliminating contamination risk.
2Temperature
If a water reservoir and fixed pump system is used for temperature management, then temperature control capability is provided, but device complexity and cleaning difficulty increase
Solution Approach 1:
By making the entire fluid circuit disposable, the system eliminates complex cleaning procedures altogether. The disposable circuit is pre-sterilized and discarded after use, transforming a complex cleaning maintenance task into a simple replacement operation.
Solution Approach 2:
The fluid-containing components (reservoir, tubes, pump) are extracted as a separate disposable module from the main temperature control system. This allows the main system to remain simple and reusable while the complex fluid pathway is handled as a separate single-use component.
3Quantity of substance
If patient blood is passed through long external tubes, then oxygenation and circulation are achieved, but significant heat loss occurs requiring high energy input
Solution Approach 1:
The temperature management fluid circuit is merged with the blood circulation system through a heat exchanger integrated into the oxygenator. This allows direct thermal coupling between the circulating blood and the temperature-controlled fluid, minimizing heat loss along external tubes while maintaining effective blood circulation and oxygenation.
Solution Approach 2:
A temperature management fluid acts as an intermediary medium between the heat source/sink and the patient's blood. This intermediary fluid circulates through the heat exchanger, transferring thermal energy efficiently to or from the blood without requiring direct contact, thereby reducing heat loss in external tubing.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively maintains patient temperature while significantly reducing the risk of contamination and simplifying cleaning processes, making it suitable for both stationary and mobile applications.
Implementation Method 1
the oxygenators of the ECLS systems offer an integrated heat exchanger
Data Source
AI summary
The present disclosure relates to a system for temperature management for patients in stationary and mobile ECLS and/or ECMO therapy, with a disposable and a fluid circuit, wherein the disposable comprises a reservoir or bag provided with at least one supply line and a drain line, further comprising a pumping unit element as part of the disposable, by means of which liquid in the reservoir or bag can be pumped through the fluid circuit, wherein in the mounted state of the system all fluid-guiding parts of the system are completely encapsulated and separated from intracorporeal and extracorporeal blood circuit of the patient undergoing the ECLS and/or ECMO therapy.